bowel dysfunction Transanal irrigation
Conditions
Interventions
The Bulb Catheter will be inserted into the anus and anal canal as a part of
the TAI procedure.
One Bulb catheter of each size used at two different occasions are considered
enough to evaluate the B
Sponsors
Wellspect HealthCare
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent. 2. Female and male aged 18 - 80 years. 3. Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy. 4. Able to read, write and understand information given to them regarding the study.
Exclusion criteria
Exclusion criteria: 1. Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site). 2. Previous enrolment in the present clinical investigation. 3. Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation. 4. Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare. 5. Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product. 6. Known anal or colorectal stenosis. 7. Active inflammatory bowel disease. 8. Acute diverticulitis. 9. Colorectal cancer. 10. Ischemic colitis. 11. Any anal or colorectal surgery within the previous 3 months. 12. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks. 13. Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate. 14. Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Yes / No confirmation if catheter stay in place during water instillation by assessment of expulsion of catheter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint: Emptying of bowel similar to regular use of Navina Smart system & Leakage similar to regular use of Navina Smart system. | — |
Countries
Netherlands
Outcome results
None listed